Effect of vitamin D supplementation on levels, bone turnover markers and clinical outcomes during induction chemotherapy in children with acute lymphoblastic leukemia: a randomized double-blind placebo-controlled trial

Objective
Low vitamin D levels are associated with poor bone health and more infections in children undergoing chemotherapy for acute lymphoblastic leukemia (ALL). Vitamin D supplementation may improve the outcome. The lack of randomized trials prompted this study to assess the effect of vitamin D supplementation on bone mineral homeostasis and outcome during and after induction of remission.


Patients and methods
Seventy newly diagnosed patients with ALL (2–16 years) were randomized into group A (Vitamin D supplementation; 60,000 IU weekly × 6 weeks) and group B (placebo) in a double-blind placebo-controlled trial. Vitamin D and serum carboxyl-terminal telopeptide of human type I collagen (ICTP) levels were measured at baseline and after 6 months of chemotherapy.


Results

A total of 58 patients were analyzed at 6 months after nine mortalities and three dropouts. In group A, 60% of patients had inadequate vitamin D levels (<20 ng/ml) at baseline which reduced to 14% after 6 months whereas in group B, 54% of patients had inadequate levels, which increased to 60% after 6 months (
P
=0.01). Mean vitamin D levels in groups A and B were 20.2 ± 8.04 versus 21.05 ± 8.40 prechemotherapy (
P
=0.66) and 37.64 ± 15.32 versus 27.84 ± 20.02 postchemotherapy, respectively, (
P
=0.01). Mean ICTP levels in groups A and B were 1.48 ± 0.35 versus 1.43 ± 0.35 prechemotherapy (
P
=0.54) and 1.16 ± 0.31 versus 1.44 ± 0.31 postchemotherapy, respectively, (
P
=0.01). Vitamin D supplementation had no statistically significant effect on the duration of induction, febrile neutropenia, and mortality.



Conclusion
Vitamin D supplementation improved levels and reduced ICTP but had minimal impact on clinical outcomes. More trials are required to establish its effect.